Pharmaceutical particulars : מידע רוקחי

6   PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Sodium hydroxide
Water for injections

6.2 Incompatibilities

Lidocaine hydrochloride is incompatible with solutions containing sodium bicarbonate and other alkaline solutions. Therefore, 1% w/v lidocaine hydrochloride injection must not be mixed with such solutions.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Once opened, must not be stored for later use (see section 6.6). The solution is to be administered immediately after opening the ampoule.

After dilution
From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special precautions for storage

Store below 25°C.
See also section 6.3

6.5 Nature and contents of container

Esracain Injection 1% is supplied in:
Borosillicate glass ampoule type 1.
50 ampoules of 5 ml
50 ampoules of 10 ml
Not all packs may be marketed.

6.6 Special precautions for disposal and other handling
Precautions for disposal
No special requirements for disposal.
Instructions for use and handling
Only to be used if the solution is clear and colourless and the ampoules are undamaged.
The ampoules are for single use only. Discard any unused content after use.
7 REGISTRATION HOLDER

Rafa Laboratories Ltd., P.O. Box 405, Jerusalem 9100301, Israel.